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Combined O-(2-[18F]Fluoroethyl)-L-tyrosine (FET) Positron Emission Tomography (PET) and Simultaneous Magnetic Resonance Imaging (MRI) Follow-up in Re-irradiated Recurrent Glioblastoma Patients

Study Purpose

Patients with recurrent glioblastoma who are planned to receive a second course of radiation are to be included into this monocentric cohort trial. Due to multiple pre-treatments simultaneous combined positron emission tomography (PET) with O-(2-[18F]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used for treatment planning and follow-up imaging as it allows for a better distinction between treatment-related changes and viable tumor tissue.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 18 - 75 years old.
  • - histologically or magnetic resonance imaging proven recurrent glioblastoma.
  • - re-irradiation possible.
  • - willing and able to give free informed consent.

Exclusion Criteria:

  • - not willing or able to give free informed consent.
  • - pregnancy.
  • - claustrophobia.
- metallic objects or implanted medical devices in the body

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01579253
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ludwig-Maximilians - University of Munich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maximilian Niyazi, MD, MSc
Principal Investigator Affiliation Ludwig-Maximilians - University of Munich
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Nervous System Neoplasms, Central Nervous System Neoplasms, Astrocytoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms by Histologic Type, Neoplasms, Nerve Tissue
Additional Details

For glioblastoma (GBM) patients it has been proven that a [18F]FET-PET scan is very helpful especially in target volume definition and after the treatment, in turn, the combination of MRI and [18F]FET-PET is diagnostically most useful to distinguish between radiation necrosis and a real progressive disease. The response to therapy is based on the newly formulated Revised Assessment in Neuro-Oncology (RANO) criteria. Kinetic and static [18F]FET-PET scans are useful to supplement this modality and its own prognostic value concerning relapsing patients will be examined. The special feature of this study is the use of both modalities in parallel, allowing simultaneous acquisition of morphological changes, functional and molecular imaging. Secondary methodological issues are dealt with, such as the relationship between contrast uptake, perfusion and [18F]FET uptake. In this regard, the hybrid imaging may serve for hypothesis generation, as in parallel in a unique way of contrast enhancement and tracer kinetics can be investigated (simultaneous contrast-enhanced analysis and tracer application). In particular, FET kinetics are examined in more detail (for example, differences between increasing and decreasing kinetics) to find ways of how to use certain MRI sequences for better visualization of viable tumor tissue and vice versa .

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Munich, Bavaria, Germany

Status

Recruiting

Address

University of Munich, Dep. of Radiation Oncology

Munich, Bavaria, 81377

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